Vertebral Body Nerve and Vein Cauterizing System and Method

ABSTRACT

Disclosed are vertebroplasty methods that include cauterizing an inner cavity of a vertebra of a mammal, such as a human, and injecting bone cement into the vertebra. Systems and kits for performing such methods are also disclosed.

FIELD

The present application is generally directed to vertebroplasty andkyphoplasty systems and methods that include cauterization, whichinclude e.g., cauterization by heat and/or freezing (cryo-ablation) ofan inner cavity of a vertebral body prior to insertion of bone cement(such as standard bone cements, bone growing agents, bone glue, etc.)into the cavity.

BACKGROUND

Vertebroplasty is a medical procedure in which acrylic bone cement suchas Polymethyl Methacrylate (PMMA) is percutaneously injected into afractured vertebra to stabilize the vertebra. An osteoporotic fracturecan cause extreme back pain along with other symptoms, such as decreasedheight and spinal deformity or a hunchback appearance. The main goal ofvertebroplasty is to reduce pain caused by the fracture by stabilizingthe bone.

The procedure, which typically involves the minimally invasive deliveryof bone cement, such as PMMA, is typically used for a spine fracturecaused by osteoporosis, a disease that causes weakening of the bones andcan lead to fractures in the vertebral bodies. The procedure may offerearly relief to older patients suffering osteoporotic compressionfractures and refractory pain. Vertebroplasty may also be used to treatsteroid-induced osteoporotic compression fractures, vertebral bodyhemangiomas and metastatic disease of the spine. If left untreated,fractures will continue to cause pain. Posterior displacement of thevertebral body can occur, which can cause pressure on nerves of thespinal cord and can lead to neurological deficit.

Vertebroplasty stabilizes or hardens the fracture, thus reducing thepain. In particular, increasing the rigidity and strength of the bonethrough the injection and subsequent hardening of PMMA cement reducesbone deformation and painful micro-motion at the fracture site. This isthe consolidation effect.

Most patients experience pain relief within hours and are able to resumetheir daily activities within 48 hours. These procedures can even beperformed with local anesthetic only for patients with severe lungdisease who cannot tolerate sedatives well.

A problem may arise with vertebroplasty however, in that PMMAby-products may be sucked into blood and carried through micro veins inthe cancellous bone to other regions of the body, which can causeinadvertent negative results, such as an embolism in the lungs(obstruction of one of the pulmonary arteries by an embolus).

SUMMARY

Example embodiments are generally directed to vertebroplasty andkyphoplasty methods that include cauterization (by heat or freezing) ofan inner cavity of a vertebral body prior to insertion of bone cement,bone growing agents, bone glue, etc. into the cavity. The methods hereinmay reduce or eliminate extravasation of bone cement, bone glue, etc.from the vertebral body into the body into the blood stream and/or arecapable of reducing or stopping pain generated by sensitive nerve endingmicro-motion.

Other embodiments are directed to kits or systems that include devices,components or ingredients for performing the methods herein.

The foregoing has outlined rather broadly the features and technicaladvantages of the present invention in order that the detaileddescription of the invention that follows may be better understood.Additional features and advantages of the invention will be describedherein, which form the subject of the claims of the invention. It shouldbe appreciated by those skilled in the art that any conception andspecific embodiment disclosed herein may be readily utilized as a basisfor modifying or designing other structures for carrying out the samepurposes of the present invention. It should also be realized by thoseskilled in the art that such equivalent constructions do not depart fromthe spirit and scope of the invention as set forth in the appendedclaims. The novel features which are believed to be characteristic ofthe invention, both as to its organization and method of operation,together with further objects and advantages will be better understoodfrom the following description when considered in connection with theaccompanying figures. It is to be expressly understood, however, thatany description, figure, example, etc. is provided for the purpose ofillustration and description only and is by no means intended to definethe limits the invention.

BRIEF DESCRIPTION OF THE FIGURES

Non-limiting example embodiments described herein, with reference to thefollowing accompanying Figures.

FIG. 1 depicts a vertebral body having heat input therein to cauterizean inner cavity of a fractured vertebra during a vertebroplastyprocedure.

FIG. 2 depicts a vertebral body after cauterization of vessels andexposed nerve endings within the vertebral body.

FIG. 3 is a transverse cross-sectional view of a vertebral body, showingthe vertebral venous plexuses.

DETAILED DESCRIPTION

Generally provided herein are vertebroplasty and kyphoplasty methodsthat include cauterizing (e.g., by heat cauterization or bycryo-ablation) an inner cavity of a fractured vertebra of a mammal.

Also provided herein are systems and kits that include one or moreingredients or devices to be used in cauterizing or cryo-ablation of aninner cavity of a fractured vertebra in the vertebroplasty and/orkyphoplasty methods provided herein, and optionally including one ormore ingredients typically used for known vertebroplasty and/orkyphoplasty methods.

The aspects, advantages and/or other features of example embodiments ofthe invention will become apparent in view of the following detaileddescription, taken in conjunction with the accompanying drawings. Itshould be apparent to those skilled in the art that the describedembodiments of the present invention provided herein are merelyexemplary and illustrative and not limiting. Numerous embodiments ofmodifications thereof are contemplated as falling within the scope ofthe present invention and equivalents thereto.

Unless otherwise noted, technical terms are used according toconventional usage. All patents and publications mentioned in thisspecification are indicative of the level of those skilled in the art towhich the invention pertains. All publications, patent applications,patents, and other references mentioned herein are incorporated byreference in their entirety.

In describing example embodiments, specific terminology is employed forthe sake of clarity. However, the embodiments are not intended to belimited to this specific terminology.

As used herein, “a” or “an” may mean one or more. As used herein,“another” may mean at least a second or more. Furthermore, unlessotherwise required by context, singular terms include pluralities andplural terms include the singular.

Methods provided herein include vertebroplasty and kyphoplasty methods,which include cauterizing (e.g., heat cauterizing or cryo-ablation) aninner cavity of a fractured vertebra of a mammal; and thereafterinserting bone cement into the fractured vertebra of the mammal. Theterm “bone cement” is intended to encompass known and to be developedbone sealing, attaching and/or growing agents (including for examplestandard bone cements, such as PMMA, or other bone cements, bone growingagents, and/or bone glues), alone or in combination with one another,that may be used in vertebroplasty and/or kyphoplasty methods.

Cauterization may be performed using one or more methods or techniquesthat may include for example, heated fluid circulation, laser techniques(e.g., plasma laser), bi-polar/electric methods, using ultrasonicoscillating energy, microwave, cryo-ablation/cryogenic treatment oranother other method that has the effect of being able to cauterizevessels and/or exposed nerve endings within a vertebral body prior toinsertion of bone cement. According to examplary embodiments, theheating/cauterization temperature may be between 56 and 100 degreesCelsius, which may achieve blood flow stagnation and dull thesensitivity of nerve endings. Initial heat increases blood flow andfurther heat coagulates blood cell flow. Heated fluid circulation mayinclude for example, heat fluid delivery via contained vessel. Inalternate embodiment, a flexible balloon, or similar member, may includean integrated electrical circuit or mesh therewith, similar to anelectric blanket. The balloon may be inserted into a patient's bone,such as the vertebra, in a collapsed condition and can subsequentlyinflated or expanded to create a cavity or fill an existing cavity inthe bone. The electrical mesh may be sandwiched between multiple layersof material and may be remotely electrical stimulated to heat up tocauterize at least a portion of the interior cavity of the bone, orvertebral body.

In embodiments in which the cauterization is cryo-ablation or cryogenictreatment, such terms include freezing a desired area of pathologicaltissue to destroy the area, for example, by inducing cold necroses attemperatures down to −196° C. Such freezing may be performed forexample, using cryoinstruments (e.g., cryoprobes, cryoscalpels,cryoclamps, cryoneedles) that may be cooled for example using liquidnitrogen

As indicated above, a desired result of cauterization/cryo-ablation isto prevent bone cement by-products from being sucked into blood andcarried through microveins. Therefore, cauterization methods (whether byheating or cooling) that has a result of sealing such vessels to helpprevent the extravasation of bone cement or other vertebroplasty productinto the vessels, is encompassed by the present application.

An additional desired result of the present methods, which includecauterization or cryo-ablation, is to stop or reduce pain generated bysensitive nerve ending micro-motion. Hardening of bone cement reducessome of the painful micromotion at the fracture site. Pain relief isthought to be achieved by locking of bone fragments. The presentmethods, which include cauterization or cryo-ablation of the vessels andexposed nerve endings, would destroy exposed nerve endings and evenfurther reduce or even stop pain generated by the sensitive nerve endingmicro-motion. Any cauterization, or other heating or cooling method thatwould result in such exposed nerve ending destruction, is intended to beencompassed by the present application.

Insertion or delivery of bone cement into the fractured vertebra of themammal may include for example, injection of bone cement into avertebral body. Injection may be percutaneous injection or other formsof injection.

The bone cement may include one or more types of bone cement or otherfiller, bone glue and/or bone growing agents used in vertebroplasty orkyphoplasty techniques. Non-limiting examples of bone cement that may beused may include acrylic cements, such as Polymethyl Methacrylate (PMMA)bone cement alone or as part of a composition with other bone cements orother ingredients.

According to non-limiting example embodiments, the mammal may be forexample, a human.

FIG. 1 depicts a vertebral body 2, which may have a heating element 1input therein. The heating element 1 may include any heating or coolingelement that results in cauterization or cryo-ablation of an innercavity of a fractured vertebra according to the present methods. Thearrows in FIG. 1 depict for example the direction of heat cauterizing orfreezing an internal cavity of the vertebral body according to exampleembodiments.

FIG. 2 depicts a vertebral body 7, having at least one cavity 3 therein.The vertebral body may include a cortical shell 4. According to exampleembodiments, a heating element 1 (see FIG. 1) may be inserted into acavity 3 of the vertebral body 1, to cauterize or cryoablate vessels andexpose nerve endings 6 that may be exposed in the cavity 3 of thevertebral body 7. This cauterization, may help prevent or stop bonecement by-products from being sucked into blood in the vessels andcarried through the microveins in the cancellous bone 5 to other regionsof the body.

FIG. 3 depicts a top view of the blood vessels contained in onevertebral body.

Further encompassed herein are vertebroplasty methods, which includecreating a cavity in a fractured vertebra of a mammal; restoring bodyheight of the fractured vertebra; cauterizing or cryo-ablating the innercavity of the fractured vertebra; and inserting bone cement into thefractured vertebra. Such methods may further include containing thecement within the cavity, at least until the cement has an opportunityto harden within the cavity. These methods may include the cauterizingand cryo-ablation methods discussed throughout this application forexample with respect to other embodiments. The cement may include forexample, the bone cement discussed with respect to other embodimentsherein.

A cavity may be created mechanically or through other bone tamperingdevice, as in kyphoplasty techniques. An example method of creating acavity may be by using HydroCision® or by using other methods and/ortools known to those skilled in the art.

Height can be restored for example, through a collapsed end plate.Expansion may be by kyphoplasty balloon or other mechanical means tohold the endplates jacked up prior to cement or bone fillerintroduction.

According to non-limiting example embodiments, creating a cavity in afractured vertebra, restoring vertebral body height, cauterizing orcryoablation of the inner cavity, and inserting bone cement into thecavity of the fractured vertebra may be performed by the use of a singleendoscopic instrument that can perform all of these functions.

The inserting or filling of bone cement into a vertebral body mayinclude for example, filling at least 50%, 60%, 70%, etc. of the cavityin the fractured vertebra with bone cement, and does not necessarilyrequire complete filling of the vertebral body or a cavity therein withbone cement. The term is meant to encompass adding an amount of bonecement or other vertebroplasty or kyphoplasty filler to a vertebral bodyin accordance with medically indicated vertebroplasty or kyphoplastytechniques.

Also provided herein are kyphoplasty methods that may include placing aballoon into the fractured vertebra (which may be for example, acollapsed vertebra); cauterizing or cryo-ablating an inner cavity of afractured vertebra of a mammal; and inserting bone cement, such asacrylic bone cement, into the fractured vertebra of the mammal. Theinsertion may include for example percutaneously injecting bone cement.These methods may include the cauterizing and/or cryo-ablation methodsdiscussed throughout this application for example with respect to otherembodiments. The bone cement may include the bone cement discussed withrespect to other embodiments herein.

According to non-limiting example embodiments, cauterization may beperformed after a cavity is created, either mechanically or by a balloonor other cavity creation method.

According to further non-limiting example embodiments, the balloon maybe inflated after placement into the fractured vertebra.

According to non-limiting example embodiments, the cavity creationballoon in kyphoplasty methods could be the cauterization means, if theballoon is inflated for example with hot fluid.

Further non-limiting example embodiments may include insertion of a duallumen balloon into a patient, bone tampering using the balloon to createa cavity in a vertebral body while cauterizing (e.g., by insertion ofhot liquid into the balloon); inserting bone cement into a cavitycreated by the balloon; and removing the balloon. Bone cement may alsobe inserted into the cavity or into a second cavity or portion thereof,created after removal of the balloon.

Further provided herein are systems and kits for performingvertebroplasty or kyphoplasty provided herein. Such systems and kits mayinclude for example, one or more cauterizing/cryo-ablation elements,which may include for example one or more components or ingredients thatmay be used for cauterization and/or cryo-ablation in the methods andtechniques herein, such as laser devices, microwave components, fluidand/or heating devices for heated fluid circulation, cryotools, etc. . .. The methods or kits herein may also include one or more components(e.g., injection needles, imaging devices, etc) and/or ingredients (e.g.bone cement) that may be used with traditional vertebroplasty orkyphoplasty techniques, as modified to include thecauterization/cryo-ablation of the present methods.

The following examples are provided to further illustrate variousnon-limiting embodiments and techniques. It should be understood,however, that these examples are meant to be illustrative and do notlimit the scope of the claims. As would be apparent to skilled artisans,many variations and modifications are intended to be encompassed withinthe spirit and scope of the invention.

EXPERIMENTAL EXAMPLES Example 1

In this example a vertebroplasty technique is performed on a patient inneed thereof. The below method and that of Example 2, may be modifiedfor example as discussed in Example 3 below to include a cauterizationstep in accordance with the present methods.

The below procedure is an example of an outpatient procedure, but it iscontemplated that numerous modifications may be made to the techniquedepending for example, on the patient (age, weight, general health,etc), on the location in the patient of the vertebral body to betreated, and on the type and severity of the injury.

Outpatient Procedure

1. Patient is placed in a prone position with padding under the torsoand the hips in slight flexion. The arms are positioned above theshoulder, pressure points are padded, and joints are gently flexed.

2. Patient receives local anesthetic (or sedative) until the area isnumb. Using a posterior lateral approach, overlying skin, subcutaneoustissue and periosteum of T12 vertebra would be infiltrated with localanaesthetic.

3. The doctor inserts one or two needles through a small incision, andthe needle is placed in the vertebral body under direct visualizationusing fluoroscopy. (Percutaneous injection). An 11 G bone biopsy needle(OptiMed Cemento set, High Wycombe, UK), would be introduced into thecentre of the T12 vertebral body via a unilateral leftintercostovertebral route.

4. Acrylic bone cement (e.g., Polymethyl Methacrylate (PMMA)) isinjected in the vertebral body under high pressure and constantfluoroscopic guidance. Once satisfactory placement of the needle isconfirmed on fluoroscopy and CT, 4 ml of cement (PMMA) (Osteopal® VVertebroplasty; Biomet Merck, Altdorf, Switzerland) may be injected intothe vertebral body, under continuous lateral fluoroscopic control.

5. Fluoroscopy and CT images may be used to show adequate filling of thecement in the anterior two-thirds of the vertebral body. The patientwould be checked for leakage of cement.

6. Under careful fluoroscopic visualization, PMMA cement and sterilebarium or tungsten powder opacifier is slowly injected into thevertebral body, diffusing throughout the intertrabecular marrow space.The procedure is usually repeated through the contralateral pedicleunless there is adequate cross-filling of the vertebral body by theinitial injection. The total volume of injected cement ranges from fourto 12 cc. The cement sets in less than one hour and should stabilize thevertebra by forming a hard internal “cast.”

7. At the completion of the procedure the needle is removed and a singlesubcuticular stitch or a Steri-Strip is placed.

8. Following the procedure, the patient is instructed to lie flat in thesupine position for one hour to allow the cement to harden. Observationin the hospital should be continued for at least one to two hours, atwhich point most patients will be able to stand and walk with minimal orno pain.

9. Before being discharged, patients should be assessed for relief ofback pain, focal neurologic deficit, or new chest pain. Some patientsmay require nonsteroidal anti-inflammatory drugs (NSAIDs) forprocedure-related discomfort. Pain relief is often immediate but maytake up to 72 hours.

10. The radiologist should follow up with the patient by telephone oroffice visit at prescribed intervals to assess the response to treatmentand the durability of the results.

Bone cements that may be used in the present methods may be provided forexample, as two-component materials. For example, bone cements mayconsist of a powder (i.e., pre-polymerized PMMA and or PMMA or MMAco-polymer beads and or amorphous powder, radio-opacifies, initiator)and a liquid (MMA monomer, stabilizer, inhibitor). When mixed theseyield a dough-like cement that gradually hardens.

The two components are mixed and a free radical polymerization occurs ofthe monomer when the initiator is mixed with the accelerator. The bonecement viscosity changes over time from a runny liquid into a dough likestate that can be safely applied and then finally hardens into solidhardened material. The set time can be tailored to help the physiciansafely apply the bone cement into the bone bed to treat osteoporoticcompression fractures.

During the exothermic free-radical polymerization process the cementheats up while setting. This polymerization heat reaches temperatures ofaround 42-100° C. in the body. Thus, the hardened bone cement is a loadsharing entity in the body not causing bone resorption. Surgeons canjudge the curing of the PMMA bone cement by pressing their thumb on it.

Example 2

According to this example, a cauterization or cryocauterization step maybe added for example, after the patient receives anesthesia (step 2,Example 1) and before before injection or other insertion of bone cement(Step 4 in both Examples 1 and 3).

Cauterization/cryo-ablation takes place after any desired cavity hasbeen created for example, with a balloon.

Example 3

In an example of a kyphoplasty procedure, the above steps of Example 1are generally followed, with several modifications. The kyphoplastyprocedure involves for example a modification to step 3. In particular,according to an example embodiment, kyphoplasty may involve a step 3A,which includes placement of a balloon into a collapsed vertebra,followed by injection of bone cement to stabilize the fracture. Thisprocedure is more commonly performed in the hospital setting. Itrequires the use of slightly bigger needles than the vertebroplastyprocedure, and therefore there is typically slightly morepost-procedural pain.

Both procedures typically are very effective, reducing pain in almost90% of well-selected patients.

Example 4

According to this example, a cauterization or cryocauterization step maybe added for example, after the potential placement of a balloon (Step3A of Example 3), and before injection or other insertion of bone cement(Step 4 in both Examples 1 and 3).

Cauterization/cryocauterization takes place after the cavity has beencreated for example, with a balloon. According to example embodiments,the kyphoplasty balloon could become the cauterizing agent when filledwith hot fluid.

One exemplary cryo-ablation technique similar to known methods ofcryo-ablation of a uterus wall could be used.

Although the invention has been described in example embodiments, thoseskilled in the art will appreciate that various modifications may bemade without departing from the spirit and scope of the invention, andsuch modifications are therefore included herein. It is therefore to beunderstood that the inventions herein may be practiced other than asspecifically described. Thus, the present embodiments should beconsidered in all respects as illustrative and not restrictive.Accordingly, it is intended that such changes and modifications fallwithin the scope of the present invention as defined by the claimsappended hereto.

1. A vertebroplasty method, comprising: cauterizing an inner cavity of afractured vertebra of a mammal; and inserting bone cement into thefractured vertebra of the mammal.
 2. The method of claim 1, wherein thebone cement comprises Polymethyl Methacrylate (PMMA) bone cement.
 3. Themethod of claim 1, wherein the bone cement comprises at least oneingredient selected from the group consisting of bone glue and bonefiller.
 4. The method of claim 1, wherein said cauterizing is performedby a method selected from the group consisting of heat fluid deliveryvia contained vessel, laser, bi-polar, ultrasonic oscillation energy,microwave, and plasma laser treatment.
 5. The method of claim 1, whereinsaid cauterizing comprises cryo-ablation by freezing nerve endings. 6.The method of claim 1, wherein said mammal is a human.
 7. The method ofclaim 1, wherein said inserting comprises percutaneously injecting bonecement into the fractured vertebra.
 8. A vertebroplasty method,comprising: creating a cavity in a fractured vertebra of a mammal;restoring body height of the fractured vertebra; cauterizing the cavityof the fractured vertebra; and inserting bone cement into the fracturedvertebra.
 9. The method of claim 8, further comprising containing thebone cement within the cavity.
 10. The method of claim 8, wherein saidinserting comprises filling at least 50% of the cavity in the fracturedvertebra with bone cement.
 11. The method of claim 8, wherein saidinserting comprises percutaneously injecting bone cement into thefractured vertebra.
 12. The method of claim 8, wherein the bone cementcomprises acrylic bone cement.
 13. The method of claim 8, wherein thebone cement comprises Polymethyl Methacrylate (PMMA) bone cement. 14.The method of claim 8, wherein the bone cement comprises at least oneingredient selected from the group consisting of bone glue and bonefiller.
 15. The method of claim 8, wherein said cauterizing is performedby a method selected from the group consisting of heat fluid deliveryvia contained vessel, laser, bi-polar, ultrasonic oscillation energy,microwave, and plasma laser treatment.
 16. The method of claim 8,wherein said cauterizing comprises cryo-ablation by freezing nerveendings.
 17. The method of claim 8, wherein said mammal is a human. 18.The method of claim 8, wherein said creating a cavity, restoring bodyheight, cauterizing, and inserting cement steps are performed by the useof a single endoscopic instrument.
 19. A kyphoplasty method, comprising:placing a balloon into a vertebra of a mammal; cauterizing an innercavity of the vertebra; and inserting bone cement into the vertebra. 20.The method of claim 19, wherein the balloon is inflated after placementinto the collapsed vertebra.
 21. The method of claim 19, wherein theinserting comprises percutaneously injecting bone cement into thefractured vertebra.
 22. The method of claim 19, wherein the bone cementcomprises Polymethyl Methacrylate (PMMA) bone cement.
 23. The method ofclaim 19, wherein the bone cement comprises at least one ingredientselected from the group consisting of bone glue and bone filler.
 24. Akit for performing vertebroplasty, comprising: a tool for creating aworking channel within a patient; a tool for creating a cavity within avertebral body; at least one cauterizing element for cauterizing aninterior portion of a vertebral body; and a device for injecting bonecement into the vertebral body.